Effects of HIIT on HRV in Sub-acute Post-stroke Patients

NCT06132516 | Active Not Recruiting

• 1 other identifier: 2023-E(AVC)-V2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Objective. To assess the effect of innovative "High-Intensity Interval Training" (HIIT) on Heart Rate Variability, a strong biomarker of positive outcome after stroke. Design. A randomized controlled study with blinded assessment of the main criteria. Population. NIHSS\<20 post-stroke patients, hospitalized in secondary care stroke-units within the first 3 months (sub-acute phase). Selection. Eligibility test on a semi-recumbent cycloergometer Intervention. In addition to a standard neurorehabilitation program (3±1 sessions daily, including cognitive and occupational therapy, physiotherapy with strengthening-stretching exercises), the aerobic group will benefit from a HIIT procedure (HIIT group) with a semi-recumbent cycloergometer, for 6 weeks representing 16 sessions; while the non-aerobic group will undertake a "Low-Intensity Group-Gymnastic Training" (Control or LIGT Group) (=segmental strengthening-stretching and proprioceptive exercises mainly), with the same training volume and frequency for both groups. Main outcome measure. Standard Deviation of Normal-to-Normal RR intervals (SDNN) from 24h Holter-ECG recordings at W4, W8 and M6. Modifications in patients' medical management are expected, as generalization of AT in moderate to severe stroke patients at the sub-acute phase, with "Low volume HIIT" and simple devices.

Conditions

Stroke

Keywords

Acute post-stroke phase Rehabilitation; HIIT; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• SDNN

  Standard Deviation of all Normal-to-Normal RR intervals, recorded with a 24h-Holter ECG.

  Week 1, Week 8, Month 6

Secondary Outcomes (3)

• HRV

  Week 1, Week 8, Month 6

• Dose Ratio

  Week 2 to Week 7

• VO2peak

  Week1 Vs Week 8

Study Arms (2)

High Intensity Interval Training (HIIT)

EXPERIMENTAL

HIIT 16 sessions of 12 to 30 minutes, over 6 weeks.

Other: HIIT

Low Intensity Group Training (LIGT)

PLACEBO COMPARATOR

LIGT 16 sessions of 12 to 30 minutes, over 6 weeks.

Other: LIGT

Interventions

HIIT OTHER

High Intensity Interval Training On semi-recumbent ergocyclometer, after a symptom-limited graded exercise Test

High Intensity Interval Training (HIIT)

LIGT OTHER

Low Intensity Group Training Group gymnastics, mainly with short static stretching/strengthening tasks.

Low Intensity Group Training (LIGT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first-ever hemispheric stroke, with consistent clinical and neuroimaging signs
• \<3 month
• NIHSS \<20 in acute care

You may not qualify if:

• age\<18 years-old
• diabetes mellitus complicated by neuropathy or autonomic dysfunction; or any other concomitant nervous system, cardiac or pulmonary disease possibly affecting the autonomic nervous system ie:
• myocardial infarction\< 6 months,
• myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy, class 3 and 4 heart failure,
• severe conduction abnormalities and arrhythmias, including chronic atrial fibrillation,
• mechanical ventilation,
• beta-blockers with no alternative options, pharmacological mandatory treatment possibly affecting the autonomic nervous system and HRV.
• severe cognitive impairment inconsistent with free, informed and written consent or questionnaire filling

Sponsors & Collaborators

• Hôpital Léon Bérard: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Dr BARTHOLOMEI MN

Hyères, PACA, 83418, France

Location

Related Publications (5)

• Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

  PMID: 8737210 BACKGROUND

• Colivicchi F, Bassi A, Santini M, Caltagirone C. Prognostic implications of right-sided insular damage, cardiac autonomic derangement, and arrhythmias after acute ischemic stroke. Stroke. 2005 Aug;36(8):1710-5. doi: 10.1161/01.STR.0000173400.19346.bd. Epub 2005 Jul 14.

  PMID: 16020766 BACKGROUND

• Saunders DH, Sanderson M, Hayes S, Johnson L, Kramer S, Carter DD, Jarvis H, Brazzelli M, Mead GE. Physical fitness training for stroke patients. Cochrane Database Syst Rev. 2020 Mar 20;3(3):CD003316. doi: 10.1002/14651858.CD003316.pub7.

  PMID: 32196635 BACKGROUND

• Fyfe-Johnson AL, Muller CJ, Alonso A, Folsom AR, Gottesman RF, Rosamond WD, Whitsel EA, Agarwal SK, MacLehose RF. Heart Rate Variability and Incident Stroke: The Atherosclerosis Risk in Communities Study. Stroke. 2016 Jun;47(6):1452-8. doi: 10.1161/STROKEAHA.116.012662. Epub 2016 May 5.

  PMID: 27217501 BACKGROUND

• Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.

  PMID: 24846875 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier Gavarry

  Toulon University, STAPS Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator of the main measurement criterion (Holter-ECG/24h) receives anonymous data by secure e-mail, without ever meeting the patients or their records. A blind component is introduced for patients, via the information given about a comparison between 2 types of physical activity.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medecine Doctor

Model Details: A randomized controlled 2-arms parallel trial, with intention-to-treat procedure.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 15, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As soon as leading article is first published
• Access Criteria: Corresponding relevant Editor or Meta-analyses needs. Other detailed request will be examined.

Locations

FR (1)